MODIFIED ENZYMATIC BUN REAGENT— 510(k) K872484

Name: FDA 510(k) clearance K872484
Creator: U.S. Food and Drug Administration
Published: 1987-08-19

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K872484 for MODIFIED ENZYMATIC BUN REAGENT, Substantially Equivalent on 1987-08-19. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1987-06-24
Decision date: 1987-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Lakes, FL, US

Download summary PDF View on FDA.gov ↗

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